drugset / Trial / NCT02426736
Effect of Dexamethasone Dose and Route on Duration of Interscalene Block After Outpatient Shoulder Surgery
RandomizedFactorialQuadruple-blindTreatment
Summary
In this factorial design study, 280 participants having outpatient, arthroscopic shoulder surgery will be randomized into 4 equal sized groups. All participants will receive a standardized interscalene brachial plexus block and 4mg or 8mg of dexamethasone given by the intravenous or perineural (by the nerve with the nerve block) route just prior to their surgery. The purpose of this study is to determine which dose and route of dexamethasone provides the longest duration of pain control and the fewest side effects after surgery. The investigators hypothesize that giving dexamethasone by the perineural route, and by higher doses, will result in the longer durations of pain control, without increased side effects.
Timeline
- Start
- 2015-06-25
- Primary completion
- 2016-07-12
- Completion
- 2017-01-12
Publications
- Background Fortier J, Chung F, Su J. Unanticipated admission after ambulatory surgery--a prospective study. Can J Anaesth. 1998 Jul;45(7):612-9. doi: 10.1007/BF03012088.
- Background Hughes MS, Matava MJ, Wright RW, Brophy RH, Smith MV. Interscalene brachial plexus block for arthroscopic shoulder surgery: a systematic review. J Bone Joint Surg Am. 2013 Jul 17;95(14):1318-24. doi: 10.2106/JBJS.L.01116. No abstract available.
- Background Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
- Background Wu CL, Rouse LM, Chen JM, Miller RJ. Comparison of postoperative pain in patients receiving interscalene block or general anesthesia for shoulder surgery. Orthopedics. 2002 Jan;25(1):45-8. doi: 10.3928/0147-7447-20020101-15.
- Background Boezaart AP. Continuous interscalene block for ambulatory shoulder surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):295-310. doi: 10.1053/bean.2002.0239.
- Background Choi S, Rodseth R, McCartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014 Mar;112(3):427-39. doi: 10.1093/bja/aet417. Epub 2014 Jan 10.
- Background Bailard NS, Ortiz J, Flores RA. Additives to local anesthetics for peripheral nerve blocks: Evidence, limitations, and recommendations. Am J Health Syst Pharm. 2014 Mar 1;71(5):373-85. doi: 10.2146/ajhp130336.
- Background Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49.
- Background Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.
- Background Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.
- Background Tandoc MN, Fan L, Kolesnikov S, Kruglov A, Nader ND. Adjuvant dexamethasone with bupivacaine prolongs the duration of interscalene block: a prospective randomized trial. J Anesth. 2011 Oct;25(5):704-9. doi: 10.1007/s00540-011-1180-x. Epub 2011 Jun 17.
- Background Kim YJ, Lee GY, Kim DY, Kim CH, Baik HJ, Heo S. Dexamathasone added to levobupivacaine improves postoperative analgesia in ultrasound guided interscalene brachial plexus blockade for arthroscopic shoulder surgery. Korean J Anesthesiol. 2012 Feb;62(2):130-4. doi: 10.4097/kjae.2012.62.2.130. Epub 2012 Feb 20.
- Background Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15.
- Background Kawanishi R, Yamamoto K, Tobetto Y, Nomura K, Kato M, Go R, Tsutsumi YM, Tanaka K, Takeda Y. Perineural but not systemic low-dose dexamethasone prolongs the duration of interscalene block with ropivacaine: a prospective randomized trial. Local Reg Anesth. 2014 Apr 5;7:5-9. doi: 10.2147/LRA.S59158. eCollection 2014.
- Background De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
- Background Price C, Arden N, Coglan L, Rogers P. Cost-effectiveness and safety of epidural steroids in the management of sciatica. Health Technol Assess. 2005 Aug;9(33):1-58, iii. doi: 10.3310/hta9330.
- Background Latham JM, Fraser RD, Moore RJ, Blumbergs PC, Bogduk N. The pathologic effects of intrathecal betamethasone. Spine (Phila Pa 1976). 1997 Jul 15;22(14):1558-62. doi: 10.1097/00007632-199707150-00004.
- Background Williams BA, Hough KA, Tsui BY, Ibinson JW, Gold MS, Gebhart GF. Neurotoxicity of adjuvants used in perineural anesthesia and analgesia in comparison with ropivacaine. Reg Anesth Pain Med. 2011 May-Jun;36(3):225-30. doi: 10.1097/AAP.0b013e3182176f70.
- Background Sondekoppam RV, Uppal V, Ganapathy S. Intravenous or perineural dexamethasone for interscalene brachial plexus block: the equivalence not yet proven. Br J Anaesth. 2014 Jan;112(1):175-6. doi: 10.1093/bja/aet454. No abstract available.
- Background Fields KG, YaDeau J. Dexamethasone for increasing analgesic duration of single-shot inter-scalene block. Br J Anaesth. 2014 Jan;112(1):176-7. doi: 10.1093/bja/aet455. No abstract available.
- Background Martinez V, Fletcher D. Dexamethasone and peripheral nerve blocks: on the nerve or intravenous? Br J Anaesth. 2014 Sep;113(3):338-40. doi: 10.1093/bja/aeu144. Epub 2014 Jun 6. No abstract available.
- Background Albrecht E, Kern C, Kirkham KR. Perineural vs intravenous administration of dexamethasone: more data are available. Br J Anaesth. 2015 Jan;114(1):160. doi: 10.1093/bja/aeu421. No abstract available.
- Background Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14.
- Holland D, Amadeo RJJ, Wolfe S, Girling L, Funk F, Collister M, Czaplinski E, Ferguson C, Leiter J, Old J, MacDonald P, Dufault B, Mutter TC. Effect of dexamethasone dose and route on the duration of interscalene brachial plexus block for outpatient arthroscopic shoulder surgery: a randomized controlled trial. Can J Anaesth. 2018 Jan;65(1):34-45. doi: 10.1007/s12630-017-0989-7. Epub 2017 Nov 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 4 mg | Intravenous |
| Comparator | Dexamethasone | Small molecule | 8 mg | Intravenous |
| Comparator | Bupivacaine | Other / unclassified | 0.5 % | — |
| Comparator | Bupivacaine | Other / unclassified | 30 ml | — |
Indications
No indication recorded.